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NCT Number: NCT04775368

Fibromyalgia Syndrome in France: The Role of Assessment and Management of Sleep Disorders

The FIBOBS study is a multi-centered, observational, prospective study carried out within specialized chronic pain structures (CPS) in France. It will estimate the prevalence of sleep disorders, divided into three categories (poor quality of sleep in general, sleep apnea syndrome, restless legs syndrome), using self-questionnaires in patients with Fibromyalgia Syndrome (FMS) consulting within a CPS. The interaction between these sleep disorders and other symptoms of FMS will also be analyzed using self-administered questionnaires. Based on the hypothesis that sleep disorders associated with FMS are only imperfectly assessed and/or treated in CPS, the FIBOBS study will also interview pain physician in order to know both the diagnostic tools used and the recommended management when sleep disorders are suspected in the context of FMS. In addition, this study will provide a better understanding of the symptoms of FMS, their impact and how patients feel.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie - CETD, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old
  • Read, write and understand the French language
  • Patient with a diagnosis of Fibromyalgia Syndrome according to ACR 2010 criteria: Painful symptoms present at the same intensity for at least 3 months, WPI ≥ 7 and SSS ≥ 5 OR 3 ≤ WPI ≤ 6 and SSS ≥ 9, Any other cause responsible for chronic osteoarticular pain must be excluded.Primary or secondary fibromyalgia is eligible, at the discretion of the investigator.
  • Patient seen in consultation for the first time or for a follow-up visit if the patient has already been followed up in the specialized chronic pain structure for less than a year.
  • Have access to an internet connection (for the realization of the "patient questionnaire")
  • Patient affiliated to a social security system
  • Written and signed informed consent

Exclusion criteria

  • Patient undergoing anti-cancer treatment or having completed treatment less than 2 years ago
  • Patient under guardianship, deprived of liberty, safeguard of justice
  • Pregnant or breastfeeding women
  • Patient presenting a serious psychiatric pathology that does not allow compliance with the completion of the questionnaires (at the discretion of the investigator)
  • Refusal to participate in research

Treatment and study plan

Administering diagnosis orientation questionnaires for the screening of possible sleep disorders

Other

Several diagnosis orientation self-questionnaires will be conducted by the patient following his or her inclusion in order to detect, among other things, possible sleep disorders.

Primary outcomes

  1. Assessing the prevalence of sleep disorders in general in patients with FMS

    Time frame: Only once, by the patient within 14 days of inclusion.

    The prevalence of sleep disorders will be estimated from the results of the Pittsburgh Sleep Quality Index Questionnaire (PSQI) which is a generic, validated 19-item self-administered questionnaire for measuring sleep problems.

  2. Assessing the prevalence of sleep disorders for the specific risk of sleep apnea syndrome in patients with FMS

    Time frame: Only once, by the patient within 14 days of inclusion.

    The prevalence of sleep disorders for the specific risk of sleep apnea syndrome will be estimated from the results of the STOP-BANG questionnaire. This questionnaire guide the diagnosis of sleep apnea syndrome and is composed of 8 items.

  3. Assessing the prevalence of sleep disorders for the specific risk of restless legs syndrome in patients with FMS

    Time frame: Only once, by the patient within 14 days of inclusion.

    The prevalence of sleep disorders will be estimated from the results of the simple question which is a rapid screening tool that provides a diagnosis of probable restless legs syndrome (RLS). Patients who answer positively to this question will complete the International Restless Legs Syndrome (IRLS) questionnaire which assesses the severity of restless legs syndrome on four levels: mild, moderate, severe and very severe.

Secondary outcomes

  1. Assessing the pain severity of FMS

    Time frame: Only once, by the patient within 14 days of inclusion.

    The pain severity of the FMS will be assessed using the WPI (widespread pain index) questionnaire, which represents the generalized pain index.

  2. Assessing the symptom severity of FMS

    Time frame: Only once, by the patient within 14 days of inclusion.

    The symptom severity of the FMS will be assessed using the SSS (symptom severity scale) questionnaire, which corresponds to the symptom severity scale.

  3. Assessing the impact of the FMS on the patient's daily life

    Time frame: Only once, by the patient within 14 days of inclusion.

    The impact of the FMS on the patient's daily life will be assessed by the QIF (French version of the Fibromyalgia Impact Questionnaire (FIQ)). This validated and commonly used questionnaire makes it possible to evaluate the functional incapacity and the repercussions of the FMS on daily life by evaluating the major symptoms: pain, fatigue, sleep disorders but also morning stiffness, anxiety and depression.

  4. Assessing the feeling of pain and the impact of pain on the patient's daily behavior

    Time frame: Only once, by the patient within 14 days of inclusion.

    The painful feeling and the impact of pain on the patient's daily behavior will be assessed by the Concise Pain Questionnaire (QCD), the French version of the Brief Pain Inventory (BPI). This validated questionnaire makes it possible to assess the impact of pain on seven general aspects of the patient's life.

  5. Assess the patient's state of anxiety and depression

    Time frame: Only once, by the patient within 14 days of inclusion.

    The patient's state of anxiety and depression will be assessed using the validated HADS - Hospital Anxiety and Depression Scale questionnaire.

  6. Describe the assessment tools used by the pain physician to evaluate the main symptoms of FMS (pain, asthenia, sleep and cognitive disorders)

    Time frame: Only once, by the pain physician at the inclusion.

    The assessment tools used by the pain physician to evaluate patients' pain, asthenia, sleep disorders and memory problems will be recorded in the "physician questionnaire".

  7. Describe the therapeutic measures (drug and non-drug) in place for the management of FMS

    Time frame: Once by the physician at the inclusion, and once by the patient within 14 days of inclusion.

    Therapeutics proposed for the management of symptoms associated with FMS will be identified (names of drug and non-drug treatments, care practices).

  8. Assess the percentage of patients for whom sleep disorders have been previously diagnosed and treated.

    Time frame: Throught study completion, an average of 4 months.

    The "patient questionnaire" will identify patients already diagnosed and treated for a sleep disorder. This will allow comparison with the prevalence calculated from the three screening questionnaires.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Emile Roux

Other

Collaborators

  • University Hospital, Clermont-Ferrand
  • Walisco

Registry information

Official study title

Syndrome Fibromyalgique en France : Place de l'évaluation et de la Prise en Charge Des Troubles du Sommeil

Acronym: FIBOBS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2021
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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